Penile Fracture: A Prospective Randomized Study Comparing Erectile Function at 12 Months After Immediate Degloving Repair Versus Delayed Localized Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Erectile function
研究概览
简要总结
To prospectively compare erectile function at 12 months, utilizing the abbreviated International Index of Erectile Function-5 (IIEF-5) score, for men treated with an immediate repair versus a delayed repair.
详细描述
This was a prospective randomized study conducted at 2 tertiary level institutions in Jamaica, the University Hospital of the West Indies (UHWI) and the Kingston Public Hospital (KPH). All cases of penile fracture were recruited from the emergency room (ER) of both hospitals between the period January 2015 to January 2017 and all patients were over 18 years of age.
Information on demographics, length of time since the injury, mechanism of injury and risk factors for erectile dysfunction (Diabetes mellitus, Hypertension, Dyslipidemia, Smoking) was collected. Erectile function was objectively assessed utilizing the abbreviated International Index for Erectile Function-5 (IIEF-5), and scores at initial presentation were taken to represent the premorbid erectile function.
A block randomization sequence was created and cases were allocated 1:1 to either immediate repair (group 1) or delayed repair (group 2). Allocation sequence numbers were kept concealed in sequentially numbered folders and access was only granted to the principal investigator.
For Group 1 (Immediate repair)
Patients were admitted to hospital and underwent emergency repair via a subcoronal circumferential degloving approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with penile fracture presenting to the emergency room
排除标准
- •Suspicion of concomitant urethral injury (blood at the meatus, gross/microscopic haematuria, urinary retention)
研究组 & 干预措施
Immediate repair (group 1)
Penile explorations were done within 24 hours of presentation, under general or spinal anaesthesia.
1g Ceftriaxone IV was given.
Incision-- Subcoronal, circumferential & degloving.
Repair-- Continuous technique with inverted knots using 3-0 polyglactin suture.
All patients were discharged from hospital within 24 hours.
干预措施: Immediate repair (Procedure)
Immediate repair (group 1)
Penile explorations were done within 24 hours of presentation, under general or spinal anaesthesia.
1g Ceftriaxone IV was given.
Incision-- Subcoronal, circumferential & degloving.
Repair-- Continuous technique with inverted knots using 3-0 polyglactin suture.
All patients were discharged from hospital within 24 hours.
干预措施: Ceftriaxone (Drug)
Delayed repair (group 2)
Patients were not admitted; instead they were discharged from hospital and given an elective surgery date. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.
In an ambulatory setting, surgery was done 7 - 10 days later.
1g Ceftriaxone IV was given.
Local anaesthesia (dorsal penile nerve block): 1% Lidocaine 10cc was given.
Incision--- 2 - 3cm localized incision over the site of the "rolling" sign.
Repair--- Continuous technique with inverted knots using 3-0 polyglactin suture.
干预措施: Delayed repair (Procedure)
Delayed repair (group 2)
Patients were not admitted; instead they were discharged from hospital and given an elective surgery date. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.
In an ambulatory setting, surgery was done 7 - 10 days later.
1g Ceftriaxone IV was given.
Local anaesthesia (dorsal penile nerve block): 1% Lidocaine 10cc was given.
Incision--- 2 - 3cm localized incision over the site of the "rolling" sign.
Repair--- Continuous technique with inverted knots using 3-0 polyglactin suture.
干预措施: Lidocaine (Drug)
Delayed repair (group 2)
Patients were not admitted; instead they were discharged from hospital and given an elective surgery date. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.
In an ambulatory setting, surgery was done 7 - 10 days later.
1g Ceftriaxone IV was given.
Local anaesthesia (dorsal penile nerve block): 1% Lidocaine 10cc was given.
Incision--- 2 - 3cm localized incision over the site of the "rolling" sign.
Repair--- Continuous technique with inverted knots using 3-0 polyglactin suture.
干预措施: Ceftriaxone (Drug)
Delayed repair (group 2)
Patients were not admitted; instead they were discharged from hospital and given an elective surgery date. Oral Diclofenac Sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity.
In an ambulatory setting, surgery was done 7 - 10 days later.
1g Ceftriaxone IV was given.
Local anaesthesia (dorsal penile nerve block): 1% Lidocaine 10cc was given.
Incision--- 2 - 3cm localized incision over the site of the "rolling" sign.
Repair--- Continuous technique with inverted knots using 3-0 polyglactin suture.
干预措施: Diclofenac Sodium (Drug)
结局指标
主要结局
Erectile function
时间窗: 12 months
The International Index of Erectile Function (IIEF-5) is recorded as a total score. It is measured by a self-reported questionnaire with 5 domains, with each domain consisting of 5 options. The score ranges from 5 to 25, with 5 being the lowest score (severe erectile dysfunction) and 25 being the best score (maximal erection).
次要结局
- Penile pain during sexual intercourse(12 months)
- Penile curvature(12 months)
- Penile nodule(12 months)
- Patient satisfaction(12 months)
研究者
Dean Wong
Principal Investigator
Ministry of Health, Jamaica